Exploring the Efficacy of Homoeopathy in Controlling Essential Hypertension: A Prospective Single-blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- 1. Reduction in systolic blood pressure (SBP)
研究概览
简要总结
A single-center, prospective, participant blind, randomized, placebo-controlled, parallel group, interventional clinical trial was planned to enroll 132 participants (subjects 64, control 68) suffering from essential hypertension from April, 2011 at Mahesh Bhattacharyya Homeopathic Medical College and Hospital. The aim of this trial was to evaluate the efficacy and/or safety of homeopathic medicines in reducing systolic and/or diastolic blood pressure measured at timeline of 6 months. Inclusion criteria include age between 18 and 75 years and both sexes and more than 6 months history of suffering from essential hypertension. Exclusion criteria include any continued anti-hypertensive therapy for at least 6 months, malignant Hypertension with grave signs and symptoms as detected clinically, patients suffering from isolated systolic hypertension. The protocol needed amendments and the study was terminated prematurely.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 years and 75 years
- •Both sexes
- •Suffering from essential/primary hypertension for at least 6 months.
排除标准
- •Any continued anti-hypertensive therapy for at least 6 months
- •Malignant Hypertension with grave signs and symptoms as detected clinically
- •Patients suffering from isolated systolic hypertension
- •Patients not strictly conforming to the criteria given by JNC-7; variation of ±10 mm Hg in SBP/DBP considerable
- •Presence of severe concomitant disease(s)
- •Pregnancy, breast feeding and likelihood of pregnancy.
结局指标
主要结局
1. Reduction in systolic blood pressure (SBP)
时间窗: 6 months
2. Reduction in diastolic blood pressure (DBP)
时间窗: 6 months
次要结局
- 1. Clinical improvement in symptom scores(2. Halt of the disease progress and complications)